Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Sodium enoxaparin; Drug: Sodium Enoxaparin clexane

• Registration Number: NCT01308528
• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Brief Summary

The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.

Detailed Description

This study is a requirement of Anvisa to add a new indication for off-label drug

Study Timeline

• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-04
• Study Start: 2015-02
• Primary Completion: 2017-02
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• Men and women aged above 18 years undergoing abdominal surgery with general high risk for developing venous thromboembolism;
• Who have provided their consent by signing the consent form.

Exclusion Criteria

• Clinical evidence of Venous thromboembolism (VTE) in the selection;

• treatment requirement with anticoagulant Low Molecular Weight Heparin, Unfracted Heparin, oral anticoagulant

• suspicion or history of coagulumpathia

• Heparin, enoxaparin allergy or hypersensitiviy known to heparin, enoxaparin, but not restrict to thrombocytopenia and/or induce thombose by heparin ou enoxaparin (thrombocytopenia induce by heparin [TIH], thrombocytopenia associate with heparin [TAH] or thrombotic thrombocytopenia syndrome induce by heparin [STTIH]

• Active bleeding that can be increased by enoxaparin.

• Previous history of known intracranial hemorrhage

• Artery-venous malformation or a suspicion or known cerebral aneurism

• Spinal, Epidural ou lumbar puncture analgesia in the last 24 hours previous of the first dose of the administration of the enoxaparin.

• erosive diseases of the digestive tract especially gastroduodenal

• Uncontrolled hypertension (systolic blood pressure [BP]> 180mmHg or diastolic BP> 100 mm Hg) at randomization or clinical hypertensive urgency;

• bacterial endocarditis

• heart valve prosthesis

• characterized by severe renal insufficiency creatinine clearance <30 ml / min

• Intra-arterial thrombolic therapy

• Thrombolic therapy within 24 hours.

• Low Molecular Weight Heparin or Unfraction Heparin treatment with prophylactic dose over 48 hours before surgery or oral anticoagulant within 5 days before surgery

• disturbance of consciousness and coma

• Less than 6 months of expectative time life

• Chemical dependency

• Patient with anesthetic risk ASA III or ASA IV

• morbid obesity with Body Mass Index ≥ 40

• Chronic use of corticosteroids

• History of allergy to Unfraction Heparin, Low molecular weight heparin or pork products.

• History of severe allergic episode, systemic anaphylaxis, or major urticarial disease Steven-Johnson

• Participation in another clinical study within 12 months prior to inclusion

• Potentially fertile woman without β-HCG negative harvested until 48 hours before operation or not using acceptable contraception for participation in this study

• Changes the security checks up to 48 h before randomization:

  • Hemoglobin <10 mg / dL;
  • ALT or AST ≥ 2.5 times ULN;
  • Platelet count <100.000/mL;
  • INR ≥ 1.5;

• Any condition which in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium enoxaparin	Sodium enoxaparin	Endocris - 40 mg/0,4mL
sodium enoxaparin Clexane	Sodium Enoxaparin clexane	Clexane - 40 mg/ 0,4mL

Primary Outcome Measures

Name	Time	Method
Evaluation of Sodium enoxaparin to demonstrate non-inferiority	10 Days	Evaluation of Prophylactic use of Sodium enoxaparin to demonstrate non-inferiority for Venous Thromboembolism in High-Risk Surgery in Abdominal

Secondary Outcome Measures

Name	Time	Method
Safety of sodium enoxaparine	10 days	comparision between Endocris (sodium enoxaparin - Cristalia Prod. Quim. Farm.) versus Clexane (sodium enoxaparine - Sanofi-Aventis) in High-Risk Abdominal Surgery.
Compare the incidence of venous thromboembolism and pulmonar embolism	10 days	Compare the incidence of venous thromboembolism and pulmonar embolism between 2 groups after 30 days of surgery

Trial Locations

Locations (9)

Fundação Faculdade Regional de Medicina de São José do Rio Preto; 🇧🇷 São Jósé do Rio Preto, São Paulo, Brazil

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

Hospital Estadual Mario Covas; 🇧🇷 Santo Andre, São Paulo, Brazil

Huning Instituto de Oftalmologia e Pesquisa HIOP/HRPC; 🇧🇷 Canoas, Rio Grande do Sul, Brazil

Hospital Regional da Asa Norte; 🇧🇷 Brasília, DF, Brazil

Fundação de Desenvolvimento da Unicamp - FUNCAMP; 🇧🇷 Campinas, São Paulo, Brazil

Centro Multidisciplinar de Estudos Clínicos; 🇧🇷 Sao Bernardo do Campo, São Paulo, Brazil

Hospital das Clínicas de Riberião Preto; 🇧🇷 Ribeirão Preto, São Paulo, Brazil

Hospital São Lucas da PUCRS; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil